Emergency
Conditions
Keywords
patients, departement, requiring Rapid Sequence Intubation (RSI)
Brief summary
All patients undergoing emergent endotracheal intubation (RSI) at the Emergency Department will be screened for inclusion in this clinical study. The indication of endotracheal intubation is an exclusively clinical decision and is not affected by this study protocol in any aspect. If fulfilling the In- and exclusion criteria's, patient will be randomly assigned to one of two groups 1. C-MAC Videolaryngoscope in appropriate size 2. conventional endotracheal intubation using Macintosh Blade in appropriate size Randomization (1:1) will be based on computer-generated codes maintained in sequentially numbered opaque envelopes that will be opened immediately before randomization.
Interventions
DEVICEMacintosh blade
conventional endotracheal intubation
DEVICEC-MAC videolaryngoscope
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients requiring emergency Rapid Sequence Intubation at the emergency department * Male and Female subjects 18 years to 99 years of age * Written confirmation by a physician not involved in this study * Written informed consent by the participant (obtained afterwards) * Patient not showing remarkable rejection in participation in this study
Exclusion criteria
* Maxilla-Facial trauma * Immobilized cervical spine * Indication for fiberoptic guided intubation (known difficult airway) * Ongoing Cardio-Pulmonary-Resuscitation (CPR) * Involvement in any other clinical trial during the course of this trial, within a period of 30 days prior to its beginning or 30 days after its completion * Severe or immediately life-treating injury requiring immediate medical treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate | 10 minutes | defined as successful placement of endotracheal tube within the trachea and |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to intubation | 10 minutes | defined as time between insertion of the videolaryngoscope/ Macintosh blade into the mouth until detection of end-tidal CO2 |
| Laryngoscopic view | 10 minutes | Cormack and Lehane Score |
| Number of intubation attempts | 10 minutes | — |
| Maximum drop of saturation | 10 minutes | Spo2 will be measured continuously and documented accordingly |
| Ease of intubation (1-5) | 10 minutes | o (1) very easy, (2) easy, (3) somewhat difficult, (4) difficult, (5) impossible |
| Violations of the teeth | 10 minutes | number of patients; teeth will be inspected for potential damage and documented accordingly |
| Necessity of using further, alternative airway devices for successful intubation (if randomized airway device failed) | 10 minutes | number of patients, requiring alternate device |
| Unrecognized esophageal intubation | 10 minutes | — |
Countries
Switzerland
Outcome results
None listed